Federal Register / Vol. 88, No. 161 / Tuesday, August 22, 2023 / Notices 57131 

ACTION: Notice of application. 

SUMMARY: Pisgah Laboratories Inc. has 

applied to be registered as a bulk 

manufacturer of basic class(es) of 

controlled substance(s). Refer to 

Supplementary Information listed below 

for further drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may submit 

electronic comments on or objections to 

the issuance of the proposed registration 

on or before October 23, 2023. Such 

persons may also file a written request 

for a hearing on the application on or 

before October 23, 2023. 

ADDRESSES: The Drug Enforcement 

Administration requires that all 

comments be submitted electronically 

through the Federal eRulemaking Portal, 

which provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to 

https://www.regulations.gov and follow 

the online instructions at that site for 

submitting comments. Upon submission 

of your comment, you will receive a 

Comment Tracking Number. Please be 

aware that submitted comments are not 

instantaneously available for public 

view on https://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted and there is no 

need to resubmit the same comment. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on July 10, 2023, Pisgah 

Laboratories Inc, 3222 Old 

Hendersonville Highway, Pisgah Forest, 

North Carolina 28768, applied to be 

registered as a bulk manufacturer of the 

following basic class(es) of controlled 

substance(s): 

Controlled substance Drug 

code Schedule 

Ibogaine ........................ 7260 I 

Tapentadol .................... 9780 II 

The company plans to bulk 

manufacture the above-listed controlled 

substances in bulk for internal research 

purposes and distribution to its 

customers. No other activities for these 

drug codes are authorized for this 

registration. 

Claude Redd, 

Acting Deputy Assistant Administrator. 

[FR Doc. 2023–17971 Filed 8–21–23; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1249] 

Bulk Manufacturer of Controlled 

Substances Application: Irvine Labs 

Inc. 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Irvine Labs Inc. has applied to 

be registered as a bulk manufacturer of 

basic class(es) of controlled 

substance(s). Refer to SUPPLEMENTARY

INFORMATION listed below for further 

drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may submit 

electronic comments on or objections to 

the issuance of the proposed registration 

on or before October 23, 2023. Such 

persons may also file a written request 

for a hearing on the application on or 

before October 23, 2023. 

ADDRESSES: The Drug Enforcement 

Administration requires that all 

comments be submitted electronically 

through the Federal eRulemaking Portal, 

which provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to 

https://www.regulations.gov and follow 

the online instructions at that site for 

submitting comments. Upon submission 

of your comment, you will receive a 

Comment Tracking Number. Please be 

aware that submitted comments are not 

instantaneously available for public 

view on https://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted and there is no 

need to resubmit the same comment. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on July 10, 2023, Irvine 

Labs Inc., 7305 Murdy Circle, 

Huntington Beach, California 92647– 

3533, applied to be registered as a bulk 

manufacturer of the following basic 

class(es) of controlled substance(s): 

Controlled substance Drug 

code Schedule 

Diethyltryptamine .................... 7434 I 

Dimethyltryptamine ................. 7435 I 

Lysergic acid diethylamide ..... 7315 I 

Mescaline ................................ 7381 I 

Peyote ..................................... 7415 I 

Psilocybin ................................ 7437 I 

Psilocyn ................................... 7438 I 

The company plans to bulk 

manufacture the above listed controlled 

substances for research and 

development purposes internally and 

for distribution to its research 

customers. No other activities for these 

drug codes are authorized for this 

registration. 

Claude Redd, 

Acting Deputy Assistant Administrator. 

[FR Doc. 2023–17984 Filed 8–21–23; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. DEA–1247] 

Bulk Manufacturer of Controlled 

Substances Application: Cambrex 

Charles City 

AGENCY: Drug Enforcement 

Administration, Justice. 

ACTION: Notice of application. 

SUMMARY: Cambrex Charles City has 

applied to be registered as a bulk 

manufacturer of basic class(es) of 

controlled substance(s). Refer to 

SUPPLEMENTARY INFORMATION listed 

below for further drug information. 

DATES: Registered bulk manufacturers of 

the affected basic class(es), and 

applicants therefore, may submit 

electronic comments on or objections to 

the issuance of the proposed registration 

on or before October 23, 2023. Such 

persons may also file a written request 

for a hearing on the application on or 

before October 23, 2023. 

ADDRESSES: The Drug Enforcement 

Administration requires that all 

comments be submitted electronically 

through the Federal eRulemaking Portal, 

which provides the ability to type short 

comments directly into the comment 

field on the web page or attach a file for 

lengthier comments. Please go to 

https://www.regulations.gov and follow 

the online instructions at that site for 

submitting comments. Upon submission 

of your comment, you will receive a 

Comment Tracking Number. Please be 

aware that submitted comments are not 

instantaneously available for public 

view on https://www.regulations.gov. If 

you have received a Comment Tracking 

Number, your comment has been 

successfully submitted and there is no 

need to resubmit the same comment. 

SUPPLEMENTARY INFORMATION: In 

accordance with 21 CFR 1301.33(a), this 

is notice that on July 3, 2023, Cambrex 

Charles City, 1205 11th Street, Charles 

City, Iowa 50616–3466, applied to be 

registered as a bulk manufacturer of the 

following basic class(es) of controlled 

substance(s): 


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